FDA WARNING_LETTER - Arco Globus Trading LLC

The FDA issued a Warning Letter to Arco Globus Trading LLC, Legal Lean LLC, and Legalleanstore.com for marketing and distributing Legal Lean Syrup and Coco Loko. Based on website review and labeling, the FDA determined these products are unapproved new drugs, violating sections 301(d) and 505(a) of the FD&C Act, and misbranded under sections 502(f)(1), 502(a), and 301(a).

Legal Lean Syrup contains undeclared doxylamine, an active pharmaceutical ingredient (API) in an FDA-approved OTC drug, posing potential health risks, especially when combined with alcohol or for specific patient groups. This also means it does not meet the definition of a dietary supplement. Coco Loko, marketed for intranasal administration, is neither a conventional food nor a dietary supplement, and the safety of its ingredients (taurine, guarana) for this route is unevaluated. Both products are promoted as "street drug alternatives," further disqualifying them as dietary supplements.

The products are misbranded because they lack adequate directions for use, being prescription-type drugs for conditions not suitable for self-treatment. Legal Lean Syrup is additionally misbranded due to its false and misleading labeling by omitting doxylamine. The FDA demands immediate cessation of marketing these violative products and a written response within fifteen working days detailing corrective actions, recurrence prevention, and plans for distributed products. Failure to comply may lead to enforcement actions like seizure or injunction.